BEUDAMED
    FDA Recall Terminated

    AFFIXUS Lag Screw Drill, REF 2112-01-303, Non-Sterile, DePuy Orthopaedics, Inc., Warsaw, IN; DePuy International Leeds, England.

    Recall: Z-1643-2011 · Initiated January 12, 2011

    Recall

    Recall Number
    Z-1643-2011
    Event Number
    57916
    Firm
    Depuy Orthopaedics, Inc.
    FEI Number
    1818910
    Product Code
    LXH
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 12, 2011
    Posted
    March 22, 2011
    Terminated
    June 27, 2012
    Address
    700 Orthopaedic Dr, Warsaw, IN, 46582-3994

    Description

    AFFIXUS Lag Screw Drill, REF 2112-01-303, Non-Sterile, DePuy Orthopaedics, Inc., Warsaw, IN; DePuy International Leeds, England.

    Reason

    The firm recieved a complaint that the cannula for the drill is not the same size at both ends. The drill is grabbing the guidewire and advancing and not allowing to finish reaming, resulting in the possibility of the guide wire progressing through and penetrating the acetabulum.

    Action

    On 1/12/2011 DePuy contacted their distributors by telephone and directed the distributors to cancel all pending surgeries and discontinue use of the sets until the investigation is completed. On 1/14/2011 DePuy again contacted all distributors by telephone and directed all distributors to return the instruments to DePuy for inspection as part of the investigation.

    Distribution

    Worldwide Distribution -- US, including the states of AR, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MS, NC, NV, NY, OH, PA, TN, TX, VA, WA, WI; and country of Switzerland.

    Quantity

    296 units